| Hold Time Study Of Products |
1.0 OBJECTIVE: 1.1 To lay down the procedure for hold time study of products. 2.0 SCOPE: 2.1 This procedure is applicable for procedure for hold time study in quality assurance department. 3.0 RESPONSIBILITY: 3.1 Officer of user department shall responsible for providing samples from different time intervals and provide storage condition of materials as per requirements. 3.2 Officer QA shall responsible for collection of samples and maintain the records. 3.3 Officer Quality control shall be responsible for analysis of samples as per specifications. 3.4 Head-QA is responsible for compliance of SOP. 4.0 ABBREVIATIONS 4.1 SOP : Standard Operating Procedure 4.2 HRD : Human Resource Department To Read this SOP Click here SOP for Handling of Out Sourced Activities. 5.0 PROCEDURE: 5.1 Hold time: The storage time of the product between one stage to the next stage of processing 5.2 Hold time study: The systematic and planned study conducted to see the effect of environmental conditions on the product under study and behavior of the intermediate products at different stages before processing for the packing operation 5.3 Hold time study shall be conducted on a minimum of three batches for the products manufactured and stored as bulk finished product before packing for commercial release. 5.4 Collect the sample of relevant intermediate products & the sample size shall be equivalent to at least triple as required for analysis as per hold time study specifications. 5.5 Samples shall be labelled with relevant product details & shall be marked in bold letters as “HOLD TIME SAMPLE FOR ANALYSIS. 5.6 All such packs shall be stored in same environment condition as quarantine (Temp. NMT 25oc & RH NMT 60 %) the quarantine area where the regular storage of bulk product is being done before the packing activity. 5.7 The storage area of all such samples shall be monitored for the temperature and relative humidity during the hold time study. 5.8 The samples collected shall be subjected to chemical and microbiological evaluation as per the laid down product release specification. 5.9 QA personnel shall collect the sample from Sample container as per followed defined. 5.10 After receipt of the analysis of samples, Quality control shall Analysis the samples as specified test. 5.11 QA shall collect and review of analysis report of hold time study from QC department. 5.12 Hold time study for bulk shall be done for 30 days and sampling shall be done as per product hold time study protocol, if any reason bulk remains more than 30 days further decision shall be taken on the basis of retesting of bulk with appropriate action plans. |